Chronic Low Back PainCLBPEXPECTNCT02123680
Chronic Low Back Pain Patients' Expectations Toward Physiotherapy
An observational study of Chronic Low Back Pain, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
Trial summary
Non-specific chronic low back pain guidelines recommend rehabilitation along with a biopsychosocial approach. However, though psychological and social issues address important needs of professionals and patients, they have been scarcely developed in this area so far. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A purposive sample will be used. The investigators will aim at the recruitment of a diversified sample of patients following an intensive chronic low back pain rehabilitation program. The sample will include as many men as women, as many young than older participants (3 age groups: 18-30, 30-50, 50-65), as much variety in educational level and occupation as possible. The type of work (physical demand of employment) and career track will also be taken into account, as well as having a representation of migrants (since they are overrepresented in the back pain population58). It is estimated that data saturation should be reached with 20 participants.
Who may be able to join
- working age group (18 to 65 years old)
- have a medically confirmed non-specific chronic low-back pain
Who cannot join
- severe mental illness
- concurrent illness or co-morbidity interfering with the course of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-specific Chronic Low Back Pain Patients' Expectations Toward Physiotherapy and Physiotherapists: An Interpretive Socio-anthropological Study on Ill Persons' Experience
Non-specific chronic low back pain guidelines recommend rehabilitation along with a biopsychosocial approach. However, though psychological and social issues address important needs of professionals and patients, they have been scarcely developed in this area so far. Noteworthy, little is known about patients' expectations relative to physiotherapy for chronic low back pain (CLBP), while professional recommendations advocate taking them into consideration.
A study about patients' experience will provide knowledge about the ill person's perspective and how the physiotherapists are perceived as well as the role attributed to them. The aim of this study is, thus, to explore the experience of the patients suffering from CLBP in order to highlight their expectations toward physiotherapy services and physiotherapists.
The investigators will apply a critically interpretive socio-anthropological approach based on patients' interviews and observations in an intensive CLBP rehabilitation program. The results will help improve the care patients receive by facilitating the integration of biopsychosocial issues related to patient's expectations into the treatment.
Read the detailed description
INTRODUCTION
Chronic low back pain (CLBP) is defined as "pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without referred leg pain" persisting for at least 12 weeks. It is classified as non-specific when "not attributable to a recognisable, known specific pathology, disorder, radicular syndrome or cauda equina syndrome". It is a very frequent condition, one year prevalence being around 25% for men and 35% for women. It can greatly alter functional capacity and quality of life. Including care, sick leave and work loss, it accounts for most of the back pain related costs.
Recommended management of CLBP is multidisciplinary due to the biopsychosocial impact of this condition. Most guidelines include the patient's education, advice to stay active, anti-inflammatory and analgesic medication, exercise therapy, and spinal manipulation. Multidisciplinary rehabilitation, adjunctive analgesics, and cognitive behavioural therapy are recommended if the initial approach is not efficient. Self-management strategies, self-monitoring of status, and decision-making are also promoted.
Physiotherapy plays a role in CLBP management, in collaboration with other health and social professions. As defined by the World Confederation for Physical Therapy, "Physiotherapy provides services to individuals and populations to develop, maintain and restore maximum movement and functional ability throughout the lifespan. (…) Functional movement is central to what it means to be healthy (…).This encompasses physical, psychological, emotional, and social wellbeing
Local and international standards of physiotherapy practice advocate taking patients' expectations into consideration. Physiotherapists are also advised to take patients preferences into account, when applying evidence-based practice (EBP) guidelines. However, knowledge about the expectations of patients toward physiotherapy is limited.
This research is conducted with an interdisciplinary approach. Indeed, it takes into account both the physiotherapy and the anthropological discipline. Physiotherapists want to deepen their comprehension of the patients' needs in order to take better care of them whereas anthropologists are interested in the broader experience of chronic illness and in understanding the relationship between cares and patients. With their concepts and qualitative methods, the latter have relevant tools to answer the research question.
Expectations issues within the CLBP rehabilitation process
Commonly, expectations are understood as "a belief that someone will or should achieve something". In the health field literature, the notion of expectation is often used, although it is seldom defined. Nevertheless, three dimensions emerge from the literature on CLBP patients' expectations: effectiveness of care (diagnosis, effective treatment, pain relief), relational issues (understanding, partnership, be believed, be treated as a person), and empowerment (self-management, exercise, advice, explanation, etc). In addition, expectations appear to be influenced by the course, the prognosis and the outcome of the rehabilitation.
CLBP patients are often dissatisfied with back pain rehabilitation. As pain relief is slight, disappointment with outcome is frequent. Having a clear diagnosis is clearly expected. Thus, additional medical investigations are frequently requested to find a cause to the disease. The patients also have expectations with regard to the outcome. Health professionals are expected to demonstrate communication skills, understand emotional and physical impact, spend time with the patient, show respect and build a partnership. They are also expected to understand the personal situation, demonstrate empowering skills, and adapt their language.
The nature of CLBP thus puts health professionals in an uncomfortable position. The diagnostic uncertainty and the limited effect of therapy challenge their competencies. The professional recommendations advise to avoid complex investigations and to stay active despite the pain. This position may be difficult to have when the patient wishes to obtain a clear diagnosis or to be prescribed time to rest for example. Thus, unrecommended approaches are sometimes implemented to maintain the relationship with the patient.
Patients' expectations of a diagnosis and a cure are in line with a biomedical approach, while a biopsychosocial model applies to CLBP treatment. It requires subtle interaction to bring the patient to consider that psychosocial issues influence pain and disability without giving the impression that pain is "in the mind" or exaggerated. This is especially difficult in a context where the person feels delegitimized. Indeed, disbelief and delegitimization by health professionals are motives for dissatisfaction.
Unclear diagnosis and poor social recognition
In Social sciences, the few studies that have explored the experience of CLBP patients show that, since they face long term diagnostic uncertainty, this places them in a liminal state being both well and sick, and being neither. Struggling for a diagnosis is an important source of strain added to the experience of pain, altered moods and functional limitations. Medical validation of pain cannot be performed through medical imagery in non-specific CLBP, as the relation between findings and pain is low. Following the anthropological distinction between disease, illness and sickness, patients, find themselves with "illness" (their subjective experience of suffering), but without "disease" (medical definition of the affection) or "sickness" (social construction and recognition). Lack of clear body damage explaining pain leads to an absence of social recognition as a sick person needing to be supported by the society.
Living with CLBP: a biographical disruption
Chronic symptoms can lead to a feeling of hopelessness, depression, anger and a loss of self and identity. The loss of social role, status and identity induced by chronic illness is documented in medical socio-anthropology. As shown in socio-anthropological studies on chronic illness, there is a biographical disruption when the illness appears. The CLBP patient has to manage his life accounting for pain. Self-image is altered and a feeling of self-discrepancy, i.e. a difference between ideal and perceived self, may be experienced.
Some patients feel that there are held responsible for their suffering, when physicians situate the origin of pain "in the mind" in the absence of identified body damage. Patients often consider that physicians don't admit the limitations of medicine. Persons in unexplained pain, speak of solving the riddle which they can't resign to consider as "imagined pain". They are often convinced of the concreteness of their pain, since "you can't hurt this bad and there being nothing wrong". Some complain "having been let down" in this quest and explain they had to cope on their own with their situation.
Although these studies show the importance of taking into account the lived situations and trajectory of the ill persons since the beginning of the illness, they make little articulation between these trajectories and ill persons' expectations towards caregivers. In this study the investigators assume there are strong links between these aspects. For instance, the duration of the illness, the level of disability, its impact on the quality of life, the previous recourse to other therapists and treatments necessarily produce variations in the patients' expectations towards the physiotherapists.
Research aims
The main aim of this study is to identify CLBP patients' expectations toward physiotherapy and physiotherapists. The investigators will aim at providing a qualitative insight into the factors influencing the expectations by relating them to the experience and elements of the context in which they appear. The elements accounted for will include the representation of CLBP, physiotherapy and its therapists, the illness trajectory, the socio-economic characteristics, the techniques and the perceived relationship with the physiotherapists. Expectations will be investigated at the beginning and the end of an intensive rehabilitation program to seize how this experience answers and/or modifies the patient's expectations.
Methodology
Design: individual interviews and observations
Interviews with patients and observations of the patient-physiotherapist interactions are planned.
Interviews
Individual comprehensive interviews are a common method to provide accounts of the experience of illness.
The investigators will use semi-structured interviews based on a guide of questions. Interviews will be conducted by the anthropologists of the research team. Interviews will last around 1 hour. They will take place at the ill person's home if he/she agrees.
At the beginning of the process, 4 pilot interviews and two individual sessions (observations) will be run to refine questions and procedures, as well as adjust to unplanned practical issues.
Two interviews will take place, one at the beginning of the rehabilitation program, and the second at the end. Both interviews will be conducted by the same researcher.
Observations
With an aim of a triangulation of data, the interviews will be completed with observations of the relationship between patients and physiotherapists.
The observations will take place in the back rehabilitation unit of the university hospital. Patients will follow a 3 week intensive CLBP rehabilitation program.
Focus will be put on individual therapy sessions. More specifically, the first and the last session of the program will be observed. The investigators will choose ten patients among the twenty participants using the same purposive sampling process.
These observations will be conducted by the two anthropologists in the research team. Following the observations, all members of the research team will meet for debriefing sessions, to share visions between anthropologists and physiotherapists about the meaning of the events. This will assure taking into account both socio-anthropological concepts and physiotherapists' knowledge of the field in an interdisciplinary approach.
- Conditions
- Chronic Low Back Pain
- Keywords
- expectation, chronic illness, trajectory
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Expectations at baseline
Qualitative data on patient's expectations toward physiotherapy and physiotherapists issued from interviews and observations
Measured: 2 weeks before a rehabilitation program
Secondary outcomes (3)
Factors influencing expectations at baseline
Qualitative data on factors influencing expectations. This includes patient's characteristics (sex, age,..), representation of CLBP, representation of physiotherapy and physiotherapists, illness trajectory, socio-economic characteristics, treatment techniques and perceived relationship with the physiotherapists.
Measured: 2 weeks before a rehabilitation program
Factors influencing expectations at T2
Qualitative data on factors influencing expectations. This includes patient's characteristics (sex, age,..), representation of CLBP, representation of physiotherapy and physiotherapists, illness trajectory, socio-economic characteristics, treatment techniques, treatment outcome, intensive rehabilitation treatment experience and perceived relationship with the physiotherapists.
Measured: 2 weeks after a rehabilitation program
Expectations at T2
Qualitative data on patient's expectations toward physiotherapy and physiotherapists issued from interviews and observations
Measured: 2 weeks after a rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- HES-SO Commission scientifique du domaine santé
- Responsible party
- Sponsor
- Investigators
- Claude Pichonnaz, PT, MSc, Study director, Hautre Ecole de Santé Vaud, physiotherapy departmentRose-Anna Foley, PhD, Principal investigator, Haute Ecole de Santé Vaud, research unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123680
- Sponsor's protocol ID
- 55-O13
- Other IDs
- 38495
- Acronym
- CLBPEXPECT
- Status last verified
- Jun 2015
- First submitted
- 11 Apr 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-specific Chronic Low Back Pain Patients' Expectations Toward Physiotherapy and Physiotherapists: An Interpretive Socio-anthropological Study on Ill Persons' Experience
- ClinicalTrials.gov ID
- NCT02123680
- Acronym / sponsor ID
- CLBPEXPECT / 55-O13
- Conditions
- Chronic Low Back Pain
- Keywords
- expectation, chronic illness, trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- HES-SO Commission scientifique du domaine santé
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-specific chronic low back pain guidelines recommend rehabilitation along with a biopsychosocial approach. However, though psychological and social issues address important needs of professionals and patients, they have been scarcely developed in this area so far. Noteworthy, little is known about patients' expectations relative to physiotherapy for chronic low back pain (CLBP), while professional recommendations advocate taking them into consideration.
A study about patients' experience will provide knowledge about the ill person's perspective and how the physiotherapists are perceived as well as the role attributed to them. The aim of this study is, thus, to explore the experience of the patients suffering from CLBP in order to highlight their expectations toward physiotherapy services and physiotherapists.
The investigators will apply a critically interpretive socio-anthropological approach based on patients' interviews and observations in an intensive CLBP rehabilitation program. The results will help improve the care patients receive by facilitating the integration of biopsychosocial issues related to patient's expectations into the treatment.
Detailed description
INTRODUCTION
Chronic low back pain (CLBP) is defined as "pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without referred leg pain" persisting for at least 12 weeks. It is classified as non-specific when "not attributable to a recognisable, known specific pathology, disorder, radicular syndrome or cauda equina syndrome". It is a very frequent condition, one year prevalence being around 25% for men and 35% for women. It can greatly alter functional capacity and quality of life. Including care, sick leave and work loss, it accounts for most of the back pain related costs.
Recommended management of CLBP is multidisciplinary due to the biopsychosocial impact of this condition. Most guidelines include the patient's education, advice to stay active, anti-inflammatory and analgesic medication, exercise therapy, and spinal manipulation. Multidisciplinary rehabilitation, adjunctive analgesics, and cognitive behavioural therapy are recommended if the initial approach is not efficient. Self-management strategies, self-monitoring of status, and decision-making are also promoted.
Physiotherapy plays a role in CLBP management, in collaboration with other health and social professions. As defined by the World Confederation for Physical Therapy, "Physiotherapy provides services to individuals and populations to develop, maintain and restore maximum movement and functional ability throughout the lifespan. (…) Functional movement is central to what it means to be healthy (…).This encompasses physical, psychological, emotional, and social wellbeing
Local and international standards of physiotherapy practice advocate taking patients' expectations into consideration. Physiotherapists are also advised to take patients preferences into account, when applying evidence-based practice (EBP) guidelines. However, knowledge about the expectations of patients toward physiotherapy is limited.
This research is conducted with an interdisciplinary approach. Indeed, it takes into account both the physiotherapy and the anthropological discipline. Physiotherapists want to deepen their comprehension of the patients' needs in order to take better care of them whereas anthropologists are interested in the broader experience of chronic illness and in understanding the relationship between cares and patients. With their concepts and qualitative methods, the latter have relevant tools to answer the research question.
Expectations issues within the CLBP rehabilitation process
Commonly, expectations are understood as "a belief that someone will or should achieve something". In the health field literature, the notion of expectation is often used, although it is seldom defined. Nevertheless, three dimensions emerge from the literature on CLBP patients' expectations: effectiveness of care (diagnosis, effective treatment, pain relief), relational issues (understanding, partnership, be believed, be treated as a person), and empowerment (self-management, exercise, advice, explanation, etc). In addition, expectations appear to be influenced by the course, the prognosis and the outcome of the rehabilitation.
CLBP patients are often dissatisfied with back pain rehabilitation. As pain relief is slight, disappointment with outcome is frequent. Having a clear diagnosis is clearly expected. Thus, additional medical investigations are frequently requested to find a cause to the disease. The patients also have expectations with regard to the outcome. Health professionals are expected to demonstrate communication skills, understand emotional and physical impact, spend time with the patient, show respect and build a partnership. They are also expected to understand the personal situation, demonstrate empowering skills, and adapt their language.
The nature of CLBP thus puts health professionals in an uncomfortable position. The diagnostic uncertainty and the limited effect of therapy challenge their competencies. The professional recommendations advise to avoid complex investigations and to stay active despite the pain. This position may be difficult to have when the patient wishes to obtain a clear diagnosis or to be prescribed time to rest for example. Thus, unrecommended approaches are sometimes implemented to maintain the relationship with the patient.
Patients' expectations of a diagnosis and a cure are in line with a biomedical approach, while a biopsychosocial model applies to CLBP treatment. It requires subtle interaction to bring the patient to consider that psychosocial issues influence pain and disability without giving the impression that pain is "in the mind" or exaggerated. This is especially difficult in a context where the person feels delegitimized. Indeed, disbelief and delegitimization by health professionals are motives for dissatisfaction.
Unclear diagnosis and poor social recognition
In Social sciences, the few studies that have explored the experience of CLBP patients show that, since they face long term diagnostic uncertainty, this places them in a liminal state being both well and sick, and being neither. Struggling for a diagnosis is an important source of strain added to the experience of pain, altered moods and functional limitations. Medical validation of pain cannot be performed through medical imagery in non-specific CLBP, as the relation between findings and pain is low. Following the anthropological distinction between disease, illness and sickness, patients, find themselves with "illness" (their subjective experience of suffering), but without "disease" (medical definition of the affection) or "sickness" (social construction and recognition). Lack of clear body damage explaining pain leads to an absence of social recognition as a sick person needing to be supported by the society.
Living with CLBP: a biographical disruption
Chronic symptoms can lead to a feeling of hopelessness, depression, anger and a loss of self and identity. The loss of social role, status and identity induced by chronic illness is documented in medical socio-anthropology. As shown in socio-anthropological studies on chronic illness, there is a biographical disruption when the illness appears. The CLBP patient has to manage his life accounting for pain. Self-image is altered and a feeling of self-discrepancy, i.e. a difference between ideal and perceived self, may be experienced.
Some patients feel that there are held responsible for their suffering, when physicians situate the origin of pain "in the mind" in the absence of identified body damage. Patients often consider that physicians don't admit the limitations of medicine. Persons in unexplained pain, speak of solving the riddle which they can't resign to consider as "imagined pain". They are often convinced of the concreteness of their pain, since "you can't hurt this bad and there being nothing wrong". Some complain "having been let down" in this quest and explain they had to cope on their own with their situation.
Although these studies show the importance of taking into account the lived situations and trajectory of the ill persons since the beginning of the illness, they make little articulation between these trajectories and ill persons' expectations towards caregivers. In this study the investigators assume there are strong links between these aspects. For instance, the duration of the illness, the level of disability, its impact on the quality of life, the previous recourse to other therapists and treatments necessarily produce variations in the patients' expectations towards the physiotherapists.
Research aims
The main aim of this study is to identify CLBP patients' expectations toward physiotherapy and physiotherapists. The investigators will aim at providing a qualitative insight into the factors influencing the expectations by relating them to the experience and elements of the context in which they appear. The elements accounted for will include the representation of CLBP, physiotherapy and its therapists, the illness trajectory, the socio-economic characteristics, the techniques and the perceived relationship with the physiotherapists. Expectations will be investigated at the beginning and the end of an intensive rehabilitation program to seize how this experience answers and/or modifies the patient's expectations.
Methodology
Design: individual interviews and observations
Interviews with patients and observations of the patient-physiotherapist interactions are planned.
Interviews
Individual comprehensive interviews are a common method to provide accounts of the experience of illness.
The investigators will use semi-structured interviews based on a guide of questions. Interviews will be conducted by the anthropologists of the research team. Interviews will last around 1 hour. They will take place at the ill person's home if he/she agrees.
At the beginning of the process, 4 pilot interviews and two individual sessions (observations) will be run to refine questions and procedures, as well as adjust to unplanned practical issues.
Two interviews will take place, one at the beginning of the rehabilitation program, and the second at the end. Both interviews will be conducted by the same researcher.
Observations
With an aim of a triangulation of data, the interviews will be completed with observations of the relationship between patients and physiotherapists.
The observations will take place in the back rehabilitation unit of the university hospital. Patients will follow a 3 week intensive CLBP rehabilitation program.
Focus will be put on individual therapy sessions. More specifically, the first and the last session of the program will be observed. The investigators will choose ten patients among the twenty participants using the same purposive sampling process.
These observations will be conducted by the two anthropologists in the research team. Following the observations, all members of the research team will meet for debriefing sessions, to share visions between anthropologists and physiotherapists about the meaning of the events. This will assure taking into account both socio-anthropological concepts and physiotherapists' knowledge of the field in an interdisciplinary approach.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A purposive sample will be used. The investigators will aim at the recruitment of a diversified sample of patients following an intensive chronic low back pain rehabilitation program. The sample will include as many men as women, as many young than older participants (3 age groups: 18-30, 30-50, 50-65), as much variety in educational level and occupation as possible. The type of work (physical demand of employment) and career track will also be taken into account, as well as having a representation of migrants (since they are overrepresented in the back pain population58). It is estimated that data saturation should be reached with 20 participants.
Key inclusion criteria (2 listed)
- working age group (18 to 65 years old)
- have a medically confirmed non-specific chronic low-back pain
Key exclusion criteria (2 listed)
- severe mental illness
- concurrent illness or co-morbidity interfering with the course of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expectations at baseline
Time frame: 2 weeks before a rehabilitation program
Qualitative data on patient's expectations toward physiotherapy and physiotherapists issued from interviews and observations
3 secondary outcomes
Factors influencing expectations at baseline
Time frame: 2 weeks before a rehabilitation program
Factors influencing expectations at T2
Time frame: 2 weeks after a rehabilitation program
Expectations at T2
Time frame: 2 weeks after a rehabilitation program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Pichonnaz, PT, MSc study director
Hautre Ecole de Santé Vaud, physiotherapy department
Rose-Anna Foley, PhD principal investigator
Haute Ecole de Santé Vaud, research unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expectations at baseline (time frame: 2 weeks before a rehabilitation program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.